BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROTOMY SPONGES, XRAY DET - 18" X 18", 4 PLY

    MDR report key: 12316655 · Received August 12, 2021

    Report

    Report Number
    9680091-2021-00010
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Report Date
    October 6, 2021
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    GDY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H10 LAPAROTOMY SPONGE WAS RETURNED FOR EVALUATION. DHR REVIEW: DUP1213 WITH LOT#4102920 WAS PRODUCED DURING (B)(6) 2021. THE PRODUCTION PROCESS WAS UNDER CONTROL WITHOUT CHANGE ON EQUIPMENT, ENVIRONMENT, MATERIAL AND PRODUCT CONFIGURATION, NO ABNORMITY WAS FOUND DURING START-UP VERIFICATION. FAILURE ANALYSIS: THE DIRT THAT IS ON THE SPONGE IS THE OIL FROM THE FOLDING/PRESSING MACHINE WHERE THERE IS OIL LEAKING AROUND THE HYDRAULIC CYLINDER. A RETAIN SAMPLE OF THIS COMPLAINED LOT WAS REVIEWED, THE APPEARANCE WAS GOOD WITHOUT ABNORMITY/DIRT IN SPONGE. ROOT CAUSE: BASED ON THE ANALYSIS, THE ROOT CAUSE IS DUE TO THE SEALING RING OF THE HYDRAULIC CYLINDER WORN OUT WHICH CAUSED OIL LEAKING AROUND THE CYLINDER AREA. DURING THE FOLDING AND PRESSING PROCESS OF THE LAP SPONGE, THE LAP SPONGE HAD CONTACTED THE CYLINDER AND CONTAMINATED WITH OIL. A CORRECTIVE ACTION WAS IMPLEMENTED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THERE IS DIRT VISIBLE IN THE LAPAROTOMY SPONGES. ISSUE WAS DETECTED PRIOR TO USE. THE ITEMS ARE STORED IN A CLIMATE CONTROLLED STERILE SUPPLY STORAGE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213362 LAPAROTOMY SPONGES, XRAY DET - 18" X 18", 4 PLY LAPAROTOMY SPONGE GDY DERMA SCIENCES, INC. 4102920

    Patients

    Seq Age Sex Outcome Treatment
    1